Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

QUEST PHARMATECH REPORTS SL017 GEL DATA

Quest
PharmaTech has reported that the Phase I clinical trial results from its lead
product candidate, SL017 topical gel, demonstrated the presence of the drug at
hair follicles as detected by quantitative fluorescence microscopy. SL017 fluorescence
was detected as early as 30 minutes after application of the gel and the maximum
intensity was seen at 60 minutes. Follicular localization of the photosensitizer
suggests that photodynamic therapy (PDT) with SL017 has potential for cosmetic
hair removal.

The Phase I clinical trial was designed to study the uptake
of the photosensitizer in hair follicles, sebaceous glands and the epidermis after
topical administration to the back of 10 patients with acne. It was also designed
to evaluate the safety of the product after such application. The application
of SL017 for up to two hours under occlusion did not generate any adverse drug
reaction in the patients and the drug showed satisfactory safety profile. Comparatively
low levels of SL017 fluorescence were observed at the epidermis indicating that
PDT with SL017 should not damage the epidermis, a major limitation of other topical
PDT agents.